FDA 483 - Apitoria Pharma Private Limited - February 02, 2019

Aurobindo Pharma Limited, Unit 1, an API manufacturer in Sangareddy, India, was cited for six observations during an FDA inspection. Key issues include inadequate investigations into genotoxic impurities, deficient cleaning process validation, and insufficient process validation for revised manufacturing processes. Additionally, the firm failed to demonstrate proper analytical method validation and transfer, stored production equipment improperly, and used unapproved documents for record-keeping.